Diabetic Macular Edema Clinical Trial
Official title:
Systemic Absorption of Bevacizumab and Ranibizumab in Humans Treated for Diabetic Macular Edema
Currently, two similar medications are available for injection into the eye to treat a
variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab
(Avastin). They both have a similar mechanism of action and work equally well, however only
ranibizumab was designed for use in the eye. It is significantly more expensive per injection
than bevacizumab (by a factor of roughly 40x).
In published studies trends have been noted towards an increased rate of systemic side
effects such as heart attacks and strokes. This is presumably due to absorption of the
drug(s) from the eye into the bloodstream, however this has never been shown before. The
purpose of the investigators study was to compare the bloodstream levels of bevacizumab and
ranibizumab at various time points after injection into the eye. This required the creation
of a sophisticated assay to measure blood levels of the drugs.
see above ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03953807 -
A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated
|
Phase 4 | |
| Completed |
NCT03622580 -
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
|
Phase 3 | |
| Recruiting |
NCT06262737 -
Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
|
||
| Terminated |
NCT04603937 -
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
|
Phase 3 | |
| Terminated |
NCT04611152 -
A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
|
Phase 3 | |
| Active, not recruiting |
NCT04108156 -
This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab
|
Phase 3 | |
| Completed |
NCT02867735 -
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
|
Phase 1 | |
| Withdrawn |
NCT03629210 -
Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema
|
Phase 2 | |
| Withdrawn |
NCT02842541 -
Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema
|
Phase 1 | |
| Completed |
NCT02221453 -
Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide
|
Phase 2 | |
| Completed |
NCT02556723 -
Intravitreal Injections of Ziv-aflibercept for Macular Diseases
|
N/A | |
| Completed |
NCT02979665 -
Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
|
||
| Completed |
NCT02000102 -
Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab
|
N/A | |
| Completed |
NCT02088229 -
Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema
|
N/A | |
| Terminated |
NCT00779142 -
Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies
|
N/A | |
| Completed |
NCT01171976 -
Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
|
Phase 3 | |
| Completed |
NCT00989989 -
Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema
|
Phase 3 | |
| Completed |
NCT00683176 -
Effect of Choline Fenofibrate (SLV348) on Macular Edema
|
Phase 2 | |
| Completed |
NCT01259609 -
Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy
|
N/A | |
| Terminated |
NCT00768040 -
Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema
|
Phase 2 |